Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
Completed · Phase 1
Conditions studied: Neovascular Age Related Macular Degeneration
In brief
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Key facts
- Study ID
- NCT00383370
- Run by
- Regeneron Pharmaceuticals
- People needed
- 20
- Starts
- 2006-10-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2011-04-21
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
- ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)
You may not qualify if…
- No prior treatment with the following in the study eye:
- Subfoveal thermal laser therapy;
- Submacular surgery or other surgical intervention for the treatment of AMD;
- Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1 (Visit 2);
- PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
- Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
- Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
- Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
- Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
- History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
- Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
- Significant subfoveal atrophy or scarring.
- Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
Where it is running
- Study site — Fort Myers, Florida, United States
- Study site — Wichita, Kansas, United States
- Study site — Hagerstown, Maryland, United States
- Study site — Columbia, South Carolina, United States
- Study site — Austin, Texas, United States
- Study site — McAllen, Texas, United States
Full record on ClinicalTrials.gov
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